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The Effects of Strawberries on Blood Pressure in Postmenopausal Women

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ClinicalTrials.gov Identifier: NCT02099578
Recruitment Status : Completed
First Posted : March 31, 2014
Last Update Posted : December 16, 2016
Sponsor:
Collaborator:
California Strawberry Commission
Information provided by (Responsible Party):
Bahram Arjmandi, Florida State University

Study Description
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Brief Summary:

Cardiovascular disease (CVD) is the leading cause of death in the US. Statistics show that approximately 91% of individuals with CVD have vascular dysfunction. Hypertension is a major modifiable risk factor for CVD and approximately 60% of adults in the US are pre-hypertensive and hypertensive. In addition, the prevalence of hypertension is associated with aging in both genders; however, the increase in blood pressure (BP) in women after menopause exceeds that of men.

The development of effective and safe strategies to improve vascular function is of significance as it can have a great impact on quality of life, productivity and economic burden for the affected populations. One such alternative would be to introduce into the diet food sources that are rich in naturally occurring bioactive compounds. Thus, the long-term goal of the investigators is to provide feasible and effective dietary ways for postmenopausal women to improve their vascular function and quality of life.

Strawberries are a rich source of bioactive compounds and its total antioxidant content ranks third among all fruits and vegetables. Hence, the purpose of this study is to bring forth evidence that incorporation of strawberries into the diet will reduce blood pressure and improve cardiovascular function in pre- and stage 1-hypertensive postmenopausal women.

Sixty eligible postmenopausal women between the ages of 45 and 65 and a seated BP of ≥ 130/85 mm Hg but ≤ 160/100 mmHg at the screening visit will be randomly assigned to one of three groups:

  1. 25 g freeze-dried strawberry powder;
  2. 50 g freeze-dried strawberry powder; or
  3. placebo powder. Participants will be asked to consume the supplements for 8-weeks. Medical history, medication use, dietary intake, and physical activity will be assessed at 0-, 4-, and 8-weeks followed by blood draw. Serum levels of markers of cardiovascular function as well as oxidative stress and inflammation will be measured.

The investigators hypothesize that regular consumption of strawberry will improve cardiovascular function, decrease BP and blood markers of oxidative stress as well as inflammation. Investigators also expect the findings of this study to provide a foundation for further studies to examine the effects of long-term incorporation of strawberry into the diet and the integrity of cardiovascular system.


Condition or disease Intervention/treatment Phase
Hypertension Cardiovascular Diseases Vascular Diseases Dietary Supplement: 25 g of Freeze-dried Strawberry Powder Dietary Supplement: 50 g of Freeze-dried Strawberry Powder Dietary Supplement: Placebo Powder Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Daily Incorporation of Strawberries Into a Diet Favorably Improves Vascular Function and Lowers Aortic Blood Pressure in Postmenopausal Women With Prehypertension
Study Start Date : February 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Control Group
Freeze-dried placebo powder - two doses of 25 g/day for 8 weeks
 Dietary Supplement: Placebo Powder
Participants will be given two packets of 25 g of placebo powder and asked to consume one packet in the morning and one at night.
Other Name: California Strawberry Commission
Active Comparator: 25 g of Freeze-dried Strawberry Powder
Freeze-dried strawberry and placebo powder - one dose of 25 g/day of each for 8 weeks
 Dietary Supplement: 25 g of Freeze-dried Strawberry Powder
Participants will be given one packet of 25 g of freeze-dried strawberry powder and one packet of 25 g of placebo powder and asked to consume one packet in the morning and one at night.
Other Name: California Strawberry Commission

Dietary Supplement: Placebo Powder
Participants will be given two packets of 25 g of placebo powder and asked to consume one packet in the morning and one at night.
Other Name: California Strawberry Commission
Experimental: 50 g of Freeze-dried Strawberry Powder
Freeze-dried strawberry powder - two doses of 25 g/day for 8 weeks
 Dietary Supplement: 50 g of Freeze-dried Strawberry Powder
Participants will be given two packets of 25 g of freeze-dried strawberry powder and asked to consume one packet in the morning and one at night.
Other Name: California Strawberry Commission


Outcome Measures
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Primary Outcome Measures :
  1. Blood Pressure [ Time Frame: 8 weeks ]
    By measuring blood pressure variability and baroreflex sensitivity at rest and during physiological stress (handgrip exercise and post-exercise muscle ischemia).


Secondary Outcome Measures :
  1. Arterial Stiffness [ Time Frame: 8 weeks ]
    By assessing pulse wave velocity and augmentation index at rest and during physiological stress (handgrip exercise and post-exercise muscle ischemia).

  2. Endothelial function [ Time Frame: 8 weeks ]
    By assessing blood biomarkers of vascular function (adiponectin, leptin, endothelin-1, angiotensin II and 8-isoprostane).

  3. Oxidative Stress [ Time Frame: 8 weeks ]
    By assessing blood biomarkers of oxidative stress (superoxide dismutase, nitrate/nitrite, 8-isoprostane, malondialdehyde , and oxidized low density lipoprotein).

  4. Inflammation [ Time Frame: 8 weeks ]
    By assessing blood biomarkers of inflammation (tumor necrosis factor-α and C-reactive protein).


Eligibility Criteria
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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Postmenopausal women (1 to 10 years after natural menopause or bilateral oophorectomy)
  • 45-65 years of age
  • Seated blood pressure ≥ 130/85 mm Hg but ≤ 160/100 mm Hg
  • BMI > 25 but < 40 kg/m2

Exclusion Criteria:

  • Seated blood pressure ≤ 129/84 or ≥160/101 mmHg
  • Type I Diabetes
  • Cardiovascular disease
  • Active cancer
  • Glaucoma
  • Thyroid disease
  • Kidney disease
  • Liver disease
  • Pancreatic disease
  • Enrollment in a weight loss program
  • Heavy smokers (>20 cigarettes per day)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02099578


Locations
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United States, Florida
Florida State University
Tallahassee, Florida, United States, 32306
Sponsors and Collaborators
Florida State University
California Strawberry Commission
Investigators
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Principal Investigator: Bahram H Arjmandi, PhD, RD Florida State University
Principal Investigator: Arturo Figueroa, PhD Florida State University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Bahram Arjmandi, Margaret A. Sitton Professor and Director of the Center for Advancing Exercise and Nutrition Research on Aging, Florida State University
ClinicalTrials.gov Identifier: NCT02099578    
Other Study ID Numbers: 2013.11762
First Posted: March 31, 2014    Key Record Dates
Last Update Posted: December 16, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Bahram Arjmandi, Florida State University:
Blood pressure
Arterial stiffness
Pulse wave velocity
Strawberries
 Endothelial function
Oxidative stress
Postmenopausal women
Additional relevant MeSH terms:
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Cardiovascular Diseases
Vascular Diseases